Setaloft – action, indications, action, dosage and side effects of the drug for depression

Proven content

Setaloft is a drug from the SSRI group, i.e. selective serotonin reuptake inhibitors. This group of drugs is used to treat depression and anxiety disorders. The active substance is sertraline. The drug is available on prescription and may be reimbursed for the price. What are the indications and contraindications to the use of Setaloft? How to properly dose this drug? Can its use have side effects? What preparations must not be used with Setaloft?

Setaloft – general characteristics of the drug

Setaloft is a drug that is used in the treatment of depressive disorders, obsessive-compulsive disorders or in post-traumatic stress disorder. The active substance of the drug is sertraline, which belongs to the group of selective serotonin reuptake inhibitors.

Setaloft is available in pharmacies only with a valid prescription. It comes in the form of coated tablets with two sizes of active substance content:

1. Setaloft 50 mg – capsule-shaped, white to almost white, film-coated tablets with a score line on one side and imprint ’50’ on the other side. Size 4,6 x 10,7 mm. The tablet can be divided into equal doses;
2. Setaloft 100 mg – capsule-shaped, white to almost white, film-coated tablets with a score line on one side and imprint ‘100’ on the other side. Size 5,6 x 13,2 mm. The tablet can be divided into equal doses. 

This medicine is available in blisters (PVC / Aluminum). The package may contain 14, 20, 30, 100 film-coated tablets.

The distribution company is Actavis Group PTC ehf. The manufacturer of Setaloft is Teva Pharma SLU based in Spain. The company known today as Teva started as a small business in Jerusalem in 1901. Since then, Teva has grown significantly around the world and is now ranked among the top XNUMX pharmaceutical companies. It is also one of the world leaders in generic and specialty drugs.

What are selective serotonin reuptake inhibitors and when should they be used? Check: SSRI’s to help with depression

Setaloft – composition and action of the drug

Setaloft is primarily an antidepressant drug, and the active substance, sertraline, is responsible for its therapeutic effects. One tablet of Sertraline may contain 50 mg or 100 mg of sertraline.

Sertraline is a potent drug that belongs to the group of serotonin reuptake inhibitors, abbreviated as SSRIs.

It is worth remembering that serotonin is one of the neurotransmitters, i.e. a substance that plays an important role in communication between neurons. The junction of two neurons is called a synapse. The information-transmitting cell in front of the synapse releases a so-called mediator into the synaptic cleft, i.e. a substance that is captured and recognized by the information receiving cell behind the synapse. In this case, the mediator is serotonin. Some of the serotonin molecules are captured back by the receptors of the neuron ahead of the synapse, which is known as reuptake.

Sertraline works by blocking the transport of serotonin back into the nerve cell. As a result, the level of serotonin in the central nervous system increases.

Sertraline also blocks the transport of dopamine and norepinephrine to a lesser extent. Sertraline binds modestly to adrenergic, histamine, muscarinic, dopaminergic, serotonergic, benzodiazepine and GABA receptors.

After oral administration of the drug for 2 weeks at a dose of 50-200 mg per day, the maximum serum concentration is reached after 4,5-8,4 hours. Steady state (the state in which the rate of drug entry into the body is equal to the rate of drug elimination) is reached after 7 days of dosing. Food does not affect the bioavailability of the drug. The biological half-life is approximately 22–36 hours. The drug is rapidly converted in the liver into inactive metabolites which are excreted through the kidneys and with faeces in equal amounts. Less than 0,2% of sertraline is excreted unchanged in the urine.

The other ingredients of Setaloft are: colloidal anhydrous silica, microcrystalline cellulose, croscarmellose sodium, copovidone, lactose monohydrate, magnesium stearate, hypromellose, 3cP, hydroxypropylcellulose, macrogol 400, titanium dioxide (E171) and hypromellose 50cP.

What non-obvious symptoms might indicate depression? Check: Depression hurts. Seven physical symptoms of depression you had no idea about

Setaloft – indications for the use of the drug

Setaloft is a preparation that acts as an antidepressant. The indications for the use of this preparation are:

1. depression and prevention of recurrence of depression (in adults);
2. social anxiety disorder (in adults);
3. post-traumatic anxiety disorder (PTSD) (in adults);
4. panic disorder (in adults);
5. obsessive-compulsive disorder (in adults and children and adolescents 6-17 years old).

What is depression? How to recognize and treat it? Check: Depression – who does it affect and why? How to cure depression? [WE EXPLAIN]

Setaloft – contraindications to the use of the drug

The drug Setaloft, despite its effectiveness in the treatment of depression and anxiety disorders, cannot be used by every patient struggling with this type of ailments.

Contraindications to the use of Setaloft are:

1. hypersensitivity to sertraline or any other component of the preparation;
2. taking pimozide at the same time;
3. simultaneous intake of irreversible MAO inhibitors.

What is drug hypersensitivity and where does it come from? Read: Drugs are also allergenic

Setaloft – precautions

Before and during the use of Setaloft, follow the precautions included in the package leaflet.

Setaloft is not always suitable for everyone. Tell your doctor before taking Sertraline, if you suffer from or have suffered in the past from any of the following conditions:

1. epilepsy or a history of seizures;
2. history of manic depression (bipolar) or schizophrenia;
3. thoughts of harming or killing yourself at present or in the past;
4. serotonin syndrome or neuroleptic malignant syndrome. Rarely, these syndromes can occur in patients who are taking other medicines at the same time as sertraline;
5. low sodium levels in the blood, as this can occur with Sertraline;
6. liver disease; 
7. diabetes; 
8. bleeding disorders or if you are pregnant;
9. patient’s age – children or adolescents under 18 years of age. In children aged 6 to 17 years old Sertraline should only be used to treat obsessive compulsive disorder;
10. used electroconvulsive therapy;
11. if you have eye problems such as certain types of glaucoma;
12. sertraline may lead to false-positive urine screening tests for benzodiazepines;
13. if you have had an abnormal heart rhythm after an ECG test (electrocardiogram);
14. if you have heart disease, low potassium or magnesium levels, family history of prolongation of the QT interval, bradycardia and concomitant use of drugs that prolong the QT interval. 

It is also worth mentioning that the use of sertraline has been associated with the appearance of restlessness and the need to move, often with the inability to sit or stand still. This condition is called akathisia. The condition generally occurs within the first weeks of treatment. Contact your doctor if the dose is increased as this may be harmful in patients who develop these symptoms.

What are anxiety states and how to fight them? Check: anxiety

Setaloft – dosage and method of use

Setaloft should always be used exactly as described in the package leaflet or as directed by your doctor or pharmacist.

The recommended dose of Setaloft it depends on the patient’s age and the disease being treated.

It is usually used for the treatment of depression and obsessive-compulsive disorder in adults the effective dose is 50 mg daily. The daily dose may be increased in steps of 50 mg, at intervals of at least one week, over several weeks. The maximum recommended dose is 200 mg daily.

In turn, treatment of panic disorder, social anxiety disorder, and post-traumatic anxiety disorder should begin with doses of 25 mg dailyafter one week, increasing it to 50 mg daily. The daily dose may then be increased in steps of 50 mg each time over several weeks. The maximum recommended dose is 200 mg daily.

In younger patients aged 6 to 17 years old Setaloft should only be used to treat obsessive compulsive disorder.

For children aged 6 to 12 years, the recommended starting dose is 25 mg a day. After one week, your doctor may increase this to 1 mg a day. The maximum dose is 200 mg daily.

For in adolescents aged 13 to 17 years, the recommended starting dose is 50 mg per day. The maximum dose is 200 mg daily.

Setaloft film-coated tablets can be taken with or without food. The drug should be taken once a day, either in the morning or in the evening. The doctor decides how long the patient should take the medicine for. The duration of treatment depends on the nature of the disease and the patient’s response to treatment. It may take a few weeks for symptoms to start to improve. Treatment of depression should usually continue for 6 months after you feel better.

You should not drink alcohol during treatment.

What medications work for treating anxiety disorders? Check: Anti-anxiety drugs – types, action, natural preparations. How are anxiety disorders treated?

Setaloft – improper use of the drug

Taking more than the recommended dose of the drug or missing the indicated dose during the day is considered inappropriate use of Setaloft.

If you accidentally take too much Setaloft, tell your doctor immediately or go to the emergency department of the nearest hospital. Always take the labeled Setaloft pack with you, whether or not there is any medicine left in it. Symptoms of overdose may include: drowsiness, nausea and vomiting, increased heart rate, muscle tremors, agitation, dizziness and, in rare cases, unconsciousness.

If you forget to take a dose of Pletal, do not take a double dose to make up for the forgotten dose. If you forget to take a tablet, do not take the missed tablet. Just take the next tablet at the right time.

It is also worth remembering that the patient should not stop taking Setaloft on their own, unless the doctor tells you to do so. Your doctor should gradually reduce the dose of Setaloft over several weeks until you finally stop taking it. If you suddenly stop taking this medicine, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and tremors.

The risk of withdrawal symptoms depends on the length of treatment, dosage, and the rate at which the dose is reduced. Generally, these symptoms are mild to moderate. However, in some patients they may be severe. They usually occur within the first weeks after stopping treatment. They usually go away on their own within 2 weeks.

How to take medication correctly? Check: How to take medications effectively?

Setaloft – side effects

Setaloft, like any other drug, may cause side effects in patients. It is important to report any suspected adverse reactions after authorization of the medicinal product so that the benefit / risk balance of the medicinal product can be monitored.

The frequency classification of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare (≥ 100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

Nausea is the most commonly reported side effect with Sertraline.

Be sure to tell your doctor if you experience any of the following symptoms after taking this medicine, as they can be serious:

1. severe skin rash which causes blistering (erythema multiforme). These can appear in the mouth and tongue, these could be symptoms of a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis;
2. allergic reaction or allergy with symptoms such as itchy skin rash, breathing problems, wheezing, swelling of the eyelids, face or lips;
3. conditions such as agitation, confusion, diarrhea, high body temperature, high blood pressure, increased sweating, increased heart rate.

The above-mentioned symptoms indicate the occurrence of serotonin syndrome.

The other side effects that may occur after taking Sertraline are those that occur with different frequency.

Very common side effects after taking Sertraline (more than 1 in 10 patients):

1. nausea, dry mouth;
2. ejaculation disorders;
3. insomnia;
4. dizziness;
5. somnolence;
6. headaches;
7. diarrhea;
8. tiredness.

Common side effects after taking Sertraline (1 in 10 patients):

1. bronchitis, sore throat, runny nose;
2. decreased appetite, increased appetite;
3. depression, nervous agitation, anxiety, decreased interest in sex, nervousness, anxiety;
4. feeling strange, having nightmares, teeth grinding;
5. tremor, problems with muscle mobility (increased mobility, increased muscle tone, difficulty walking, stiffness, involuntary muscle movements, convulsions, muscle spasm without affecting normal movement), numbness and tingling sensation, disturbance in concentration, taste disturbance;
6. blurred vision;
7. ringing in the ears;
8. palpitations;
9. hot flushes;
10. yawning;
11. stomach upset, constipation, stomach pain, vomiting, gas;
12. increased sweating, skin rash;
13. back pain, joint pain, muscle pain;
14. menstruation irregular, erectile dysfunction;
15. general discomfort, chest pain, weakness, fever;
16. weight gain;
17. injuries.

Uncommon side effects after taking Sertraline (not more than 1 in 100 people):

1. gastroenteritis, ear infections;
2. tumor;
3. hypersensitivity, seasonal allergy;
4. decrease in the level of thyroid hormones;
5. thoughts of suicide, suicidal behavior, psychotic disorders, thinking abnormal, indifference, hallucinations, aggression, euphoria (feeling completely happy), paranoia;
6. amnesia, decreased feeling, involuntary muscle contractions, loss of consciousness, increased activity, migraine, convulsions, dizziness when standing up, impaired coordination, speech disorder;
7. enlarged pupils;
8. ear ache;
9. fast heartbeat, heart problems;
10. bleeding, for example from the stomach, high blood pressure, flushing, blood in the urine
11. shortness of breath, nose bleeds, difficulty breathing, possible wheezing;
12. tarry stools, dental disorders, inflammation of the esophagus, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders;
13. eye swelling, hives, hair loss, itching, purple spots on the skin, skin disorder with blistering, dry skin, fluid retention in the face (facial swelling) and cold sweat;
14. osteoarthritis, muscle tics, painful muscle spasms, muscle weakness;
15. increase in urination
16. sexual dysfunction, increased bleeding during menstruation, vaginal bleeding, female sexual dysfunction;
17. leg swelling, chills, difficulty walking, thirst;
18. increase in liver enzymes, weight loss.

Suicidal ideation and behavior have been reported during or shortly after treatment with sertraline.

Rare side effects after taking Sertraline (less than 1 in 1000 patients):

1. diverticulitis (inflammation of the bumps in the wall of organs), swollen glands, decreased number of platelets, decreased number of white blood cells;
2. severe allergic reaction;
3. endocrine disorders;
4. high cholesterol, difficulty controlling blood glucose (diabetes), decrease or increase in blood glucose, decrease in sodium in the blood;
5. physical symptoms due to stress or emotions, nightmares, drug addiction, sleepwalking, premature ejaculation;
6. coma, abnormal movements, difficulty moving, increased sensitivity, sudden severe headache (which may be a symptom of a serious condition called transient vasospasm syndrome), abnormal sensation;
7. spots in front of eyes, glaucoma, double vision, sensitivity to light, blood in the eye, unequal size of pupils, abnormal vision, tear problems;
8. heart attack, light-headedness, fainting or chest discomfort; these may be signs of changes in the electrical work of the heart (shown by electrocardiography or ultrasound of the heart), abnormal heart rhythm, slow heartbeat
9. blood circulation disorders in the arms and legs;
10. rapid breathing, progressive fibrosis of the lung tissue (interstitial lung disease), closure of the throat (laryngospasm), difficulty speaking, slower breathing, hiccups;
11. mouth ulceration, inflammation of the pancreas, blood in the stools, tongue ulceration, sore mouth;
12. liver problems, severe liver problems, yellowing of the skin and eyes;
13. skin reaction to the sun, skin swelling, hair texture abnormal, skin odor abnormal, hair rash;
14. breakdown of muscle tissue, bone disorders;
15. problem with starting urination, decreased urination;
16. nipple discharge, vaginal dryness, discharge from the genitals;
17. redness and pain in the penis and foreskin, breast enlargement, prolonged penile erection;
18. hernia, drug tolerance decreased;
19. increased cholesterol in the blood, abnormal laboratory test results;
20. abnormal semen test results, problems with blood clotting;
21. relaxation of blood vessels.

Side effects of Sertraline with an unknown frequency:

1. trismus;
2. bedwetting;
3. partial loss of vision;
4. inflammation of the colon (causing diarrhea).

In clinical trials with children and adolescents, the most common side effects were headache, insomnia, diarrhea and nausea.

What is psychotherapy and when is it worth using? Check: The course of psychotherapy – contracts, goals, methodology, duration

Setaloft – interactions with other drugs

Before starting treatment with Setaloft, please inform your doctor or pharmacist about all the medicines you are taking or have recently taken. You should also inform what medications the patient plans to take in the near future.

Taking Setaloft together with the following drugs can cause serious side effects:

1. drugs that are monoamine oxidase inhibitors (MAOIs), for example moclobemide (used to treat depression), selegiline (used to treat Parkinson’s disease), the antibiotic linezolid and methylene blue (used to treat high levels of methaemoglobin in the blood);
2. drugs for the treatment of mental disorders (pimozyd). 

Patients should notify their physician if they are taking the following medications:

1. drugs containing amphetamines (used to treat the symptoms of attention deficit hyperactivity disorder (ADHD), narcolepsy and obesity);
2. herbal medicines containing St. John’s wort (Hypericum perforatum). The effect of St. John’s wort may last for 1-2 weeks;
3. products containing the amino acid tryptophan;
4. medicines to treat severe pain (such as tramadol and buprenorphine);
5. drugs for anesthesia and chronic pain treatment (such as: fentanyl, mivacurium, suxamethonium);
6. medicines to treat migraines (such as sumatriptan);
7. medicines to prevent blood clotting (warfarin);
8. drugs for the treatment of pain and fever (metamizole);
9. medicines to treat pain / arthritis (non-steroidal anti-inflammatory NSAIDs, e.g. ibuprofen, salicylic acid);
10. sedatives (diazepam);
11. water tablets (diuretics);
12. drugs for the treatment of epilepsy (phenytoin, phenobarbital, carbamazepine);
13. drugs to treat diabetes (tolbutamide);
14. drugs used to treat excessive gastric acid secretion, peptic ulcer disease and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole);
15. medicines to treat mania and depression (lithium);
16. other drugs to treat depression (e.g. amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine);
17. drugs for the treatment of schizophrenia and other mental disorders (such as perphenazine, levomepromazine and olanzapine);
18. medicines used to treat high blood pressure, chest pain or regulate the rate and rhythm of the heart (such as: verapamil, diltiazem, flecainide, propafenone);
19. medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin);
20. medicines to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole);
21. medicines used to treat HIV / AIDS infection and hepatitis C (protease inhibitors such as ritonavir, telaprevir);
22. medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant);
23. drugs against platelet aggregation (ticlopidine);
24. drugs that increase the risk of changes in the electrical activity of the heart (such as antipsychotics and antibiotics). 

Which drugs should never be combined with each other? Check: Dangerous interactions

Setaloft and pregnancy and breastfeeding

The use of any medications or dietary supplements during pregnancy requires consultation with the attending physician. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Setaloft

The safety of sertraline in pregnant women has not yet been fully established. Make sure your doctor knows you are taking Sertraline. Medicines similar to it when used by pregnant women may increase the risk of a baby developing a serious condition called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and turn blue. These symptoms usually begin during the first XNUMX hours of a baby’s life. If this happens, contact your midwife and doctor immediately.

Your newborn baby may also have other conditions which usually begin within 24 hours after birth. Symptoms include:

1. breathing problems;
2. a bluish skin
3. too warm or too cool skin;
4. blue lips;
5. vomiting or feeding problems;
6. severe fatigue;
7. sleeping problems;
8. constant crying;
9. muscle stiffness or laxity;
10. tremors, chills, or seizures;
11. intensification of reflexes;
12. irritability;
13. low blood sugar.

Taking Setaloft at the end of pregnancy may increase the risk of serious vaginal haemorrhage shortly after birth, especially if you have a history of bleeding disorders.

There is evidence of excretion of sertraline in human milk. It can be used in breast-feeding women if, according to the doctor’s assessment, the benefits of the medicine for the mother outweigh the possible risks for the child.

How Do You Recognize Depression Symptoms During Pregnancy? Read on: Depression in pregnancy – symptoms, causes, treatment

Setaloft – replacements

Products that have the same international name and exist in the same form do not have to be substitutes, because the use of a given drug is determined by the content of the active substance, i.e. the dose of the drug.

It should be remembered that even when the dose of the active substance is similar, the patient may not always use the substitute, because he may be allergic to any of the other excipients of the drug.

Therefore, before using a substitute for Setaloft, read the package leaflet or consult your doctor or pharmacist. By deciding to replace the drug, the patient can save a few zlotys.

The preparations containing the same active substance as Setaloft and showing similar properties include:

1. ApoSerta (coated tablets);
2. Asentra (coated tablets);
3. Asertin 50 (coated tablets);
4. Asertin 100 (coated tablets);
5. Miravil (coated tablets);
6. Sastium (coated tablets);
7. Sertagen (coated tablets);
8. Sertralin Krka (coated tablets);
9. Sertraline Aurovitas (coated tablets);
10. Sertranorm (coated tablets);
11. Setaloft 100 mg (coated tablets);
12. Stimuloton (coated tablets);
13. Zoloft (coated tablets);
14. Zotral 50 mg (coated tablets);
15. Zotral 100 mg (coated tablets).

When is it worth asking the pharmacy about drug substitutes? Check: Swap when you can

Setaloft – preparation price and reimbursement

The price of the drug Setaloft may differ depending on the city in which the preparation will be purchased or the pharmacy chosen by the patient. The price of the product also depends on the number of tablets contained in the package and the content of the active substance.

The price of a package of Setaloft containing 30 tablets of 50 mg is approximately PLN 13. The reimbursed drug may be released free of charge for specific indications. In cases of mental illnesses and intellectual disabilities, the price of the drug is 30% of the basic price, i.e. about PLN 4.

How much money does the average Pole spend on treatment? Check: The Pole is not expected to see a doctor